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临床试验/NCT07704151
NCT07704151Enrolling By Invitation不适用

Custom-made Zirconia Crowns Versus Prefabricated Zirconia Crowns in Young Permanent Molars: A Randomised Controlled Trial

Jordan University of Science and Technology1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
50
试验地点
1
主要终点
Rate of Crown retention

研究概览

简要总结

This study aims to compare the clinical performance of Prefabricated Zirconia Crowns (PZCs) with that of Custom-made Zirconia Crowns (CZCs) using enhanced clinical protocols.

详细描述

Young permanent molars presenting with gross caries, pulpal treatment or developmental defects often require full coverage restorations. Recently, the Prefabricated Zirconia Crowns (PZCs) have been introduced as a biocompatible and an aesthetically pleasant option with promising outcomes. However, it comes in specific sizes, limited shades and a significant tooth preparation is often required. Custom-made zirconia crowns (CZCs), fabricated using CAD/CAM technology may; offer a favorable aesthetic alternative by ensuring a controlled tooth reduction, precise fit, better aesthetics, and improved retention. Nevertheless, the current evidence concerning its use in young permanent molars remains limited. This study will be a randomised clinical trial that aims to compare the clinical performance of (PZCs) with that of (CZCs) for the restoration of badly carious/destructed young permanent molars in children aged 7-13. Patients will be randomised into two treatment groups using an online block randomisation technique (block size of 6) and sealed-envelope techniques. Clinical parameters: retention, fracture, gingival health and marginal integrity will be evaluated at 3-month, 6-month, and 12-month intervals. In addition, treatment duration, intraoperative patient comfort and immediate postoperative patient satisfaction will be evaluated and compared. The findings of this study are expected to provide evidence on the suitability of CZC for young permanent molars in children. The Null hypothesis is that there is no difference between the two types of crowns in terms of clinical performance and child acceptance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 13 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Medically fit or with mild systemic illness (ASA I or II).
  • Children who assent to take part in the study with a valid parental consent
  • Children who have at least one first permanent molar requiring a full-coverage restoration (indications for placing a crown include: badly destructed/carious molars, or teeth affected by molar-incisor hypomineralisation (MIH))
  • Maxillary or mandibular fully erupted first permanent molars, regardless of the stage of root development.
  • A cooperative child that accepts dental treatment (Frankle Behaviour Rating Scale #3 or 4).
  • Capable of attending all follow-up sessions.

排除标准

  • Patients outside the required age range
  • Parents/child not willing to participate.
  • Medically compromised patients
  • Partially erupted permanent first molars.
  • Patients with severe malocclusion that prohibits the provision of crowns
  • First permanent molars are not indicated for full coverage restorations.
  • First permanent molars are indicated for extraction.
  • Patients with bruxism or parafunctional habits.
  • Uncooperative children (Frankle Behaviour Rating Scale #1 or 2)

结局指标

主要结局

Rate of Crown retention

时间窗: 3,6 and 12 months

Visual-tactile evaluation of the crown retention over time (crown present, loose or lost).

Rate of chipping and fracture of the crown

时间窗: 3,6 and 12 months

Clinical evaluation for the presence/absence of crown chipping or fracture

Gingival health

时间窗: 3,6 and 12 months

Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe \& Silness 1963 )

Clinical crown margin extension

时间窗: 3,6 and 12 months

Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival)

Radiographic crown margin adaptation

时间窗: 6 and 12 months

Evaluation of crown margin adaptation (Geduk et al., 2023)

Clinical crown margin adaptation

时间窗: 3,6 and 12 months

Clinical evaluation of crown margin using an explorer (Geduk et al., 2023)

次要结局

  • Time taken for intervention(Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented.)
  • Patient satisfaction(immediately following intervention.)
  • Patient's comfort(peri-operatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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